Overview Lead/Sr Computer System Validation Engineer role at Katalyst CRO. Responsibilities The CSV Lead manages quality control checks on engineering project work. The CSV Lead has 10+ years of experience in automation systems computer systems validation in a GMP environment. Assist Client in designing the validation strategy for the overall project and coordinate production of the required CSV protocols. Provide leadership to CSV team members in reviewing CSV protocols for various streams and ensuring execution in accordance with Client policy and the Project Plan. Liaise with Client Quality to ensure customer quality expectations are met with respect to CSV and provide guidance to the Client. Systems include DeltaV, Historian, MES, ABB and other DCS and OT systems. Requirements Project master validation planning. Setting of project CSV guidelines. Setting of GDP, cGMP & GAMP project guidelines. Quality review of project documentation and testing documentation. Quality review of validation documentation. Attendance at testing stages and daily client site meetings. Familiarity with relevant pharmaceutical / Life Sciences industry standards. Familiarity with validation of DeltaV, MES, Historian, ABB and other OT systems. Typically 11+ years relevant pharmaceutical / Life Sciences industry experience. Seniority level Mid-Senior level Employment type Contract Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
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